FDA 510(k)

LUSTRE GoGlow 高级 LED 贴片（PR8001，PR9001）

K号: K253878 · 2026-03-04

申请人Shenzhen Kaiyan Medical Equipment Co., Ltd.

决定日期2026-03-04

产品代码OLP

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-03-04 under 510(k) number K253878. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)?

LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) is a medical device that received FDA 510(k) clearance on 2026-03-04. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K253878.

When did LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) receive FDA 510(k) clearance?

LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) received FDA 510(k) clearance on 2026-03-04, under 510(k) number K253878.

Who is the listed applicant for LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)?

FDA 510(k)记录将深圳凯研医疗设备有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)?

The FDA product code for LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) is OLP.

列明Shenzhen Kaiyan Medical Equipment Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253932FACEGYM Pro 设备（HD-109）K254025LED颈部美容面罩（ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H）K260688Sculpt LED腰带（HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C）K260129Lumaflex面板（ZLD-05，ZLD-05A，ZLD-05APro）K252603HIGHERDOSE 身体雕塑器（型号：GS-03）K253669TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)

查看所有 24 个设备 →

相关器械（代码：OLP）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251843Erchonia EVRLErchonia Corporation K242068LED光疗面罩（RT01）Ningbo Dechang Electrical Machinery Made Co.,Ltd K243555LED光疗面罩（E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A）Shenzhen Eyco Technology Co., Ltd.K232656BLU TOTALE (型号：ENEOB852)Premier North America, Inc.K230490PMD Clean痤疮清洁，型号：4004-CABLUE-NA，4004-GREY-NA，4004-YELLOW-NA，4004-PSTO-NA，4004-LPUR-NA，4004-CABLUE-NA-INT，4004-GREY-INT，4004-YELLOW-INT，4004-PSTO-INT，4004-LPUR-INTDongguan Hunter Electronic Technology Co., Ltd.K230720LUSTRE 3XPRESS 光美疗贴片，型号：PR6001，PR5001Light Tree Ventures Europe B.V.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。